The UKMedicines and Healthcare products RegulatoryAgency(MHRA), Australian Therapeutic Goods Administration (TGA) and Health Canadaapprove KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

KIMMTRAK is the first and only treatment approved in theUK, Australia, and Canadato treat patients with unresectable or metastatic uveal melanoma

KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 08 June 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the Therapeutic Goods Administration (TGA) in Australia and Health Canada have granted marketing authorization for KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

KIMMTRAK, a gp100 and CD3 ImmTAC® (Immune mobilizing monoclonal TCRs Against Cancer) novel bispecific protein, is the first bispecific T cell engager to receive regulatory approval to treat a solid tumor, and the first and only approved therapy for the treatment of unresectable or metastatic uveal melanoma. Marketing authorization by the MHRA, TGA, and Health Canada follows recent approvals from both the U.S. Food and Drug Administration and the European Commission (EC).

Professor Sir John Bell, Immunocore Chairman and the Regius Professor of Medicine at the University of Oxford, said: “KIMMTRAK is the culmination of more than two decades of scientific discovery. Its approval in the UK, Australia, and Canada, in addition to the United States and European Union, not only represents another important milestone for Immunocore, but a breakthrough for a wholly new category of treatment and for the patients who may experience life-changing benefits, as a result.”

Dr.Joe Sacco, Consultant in Medical Oncology at the Clatterbridge Cancer Centre, said: “I am absolutely delighted that KIMMTRAK has now been licensed for the treatment of metastatic uveal melanoma. This has taken a huge commitment over many years from Immunocore, my fellow investigators and the patients who have been enrolled on the studies. This approval is a massive landmark for patients as it will be the first proven standard of care for this rare cancer and provides a significant improvement in survival for patients with this disease.” 

The approvals in the UK, Australia, and Canada of KIMMTRAK are based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. The randomized pivotal trial evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized in a 2:1 ratio to either KIMMTRAK or investigator’s choice. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p<0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the clinical trials, across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity.

Susanna Daniels, CEO of Melanoma Focus, said: “This is a first for patients with metastatic uveal melanoma, who now have a licensed treatment available.  I am thrilled at this turning point for the uveal melanoma community. We are hugely supportive of Immunocore, which has introduced a scheme to permit appropriate patients to be treated with free medicine prior to approval and public reimbursement.”

In the randomized Phase 3 trial of KIMMTRAK (tebentafusp), treatment-related adverse reactions were manageable and consistent with the proposed mechanism of action. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse events were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in